Q78. What application materials are required to be submitted when a registered product formula applies for registration (including changes) according to the new national standard?
A: The product formula has been registered according to the new national standard application for registration (including changes), the following materials need to be submitted.
(1) Application for registration of infant formula milk powder products (or application for the change);
(2) Relevant research and development demonstration materials for formula adjustment;
(3) Product formulations;
(4) Description of the production process (the registration certificate must be submitted when the process changes);
(5) Product inspection reports;
(6) Product stability research materials;
(7) Label sample.
Q79. If a registered product formula applies for registration (including changes) according to the new national standard, what are the relevant R&D demonstration materials for formula adjustment?
A: The relevant R&D demonstration materials for formula adjustment include the following.
(1) List comparison with the registered formula adjustment content (such as raw materials and food additive standards, formula composition and dosage tables, nutrient tables, etc.), and the adjustment of the situation and the reasons for the explanation;
(2) Food additive formulations are required to provide the constituent ingredients and their usage levels, as well as the implementation standards for the constituent ingredients;
(3) No less than three batches of commercial production process validation reports;
(4) A statement of the apparent variability of the formulation;
(5) The Control plan for contaminants, micro-organisms, mycotoxins and other hazardous substances that may be contained;
(6) For formulas with active strains added, relevant materials such as strain traceability, bacterial contamination prevention and control shall also be submitted.
Q80. Since the release of the new national standard, can applicants apply for registration (including changes and renewals) of product formulations according to the “National Food Safety Standard Infant Formula” (GB 10765-2010) and the “National Food Safety Standard Older Infants and Young Children Formula” (GB 10767-2010)?
A: Yes. However, from the date of implementation (22 February 2023) of the “National Food Safety Standard Infant Formula” (GB 10765-2021), “National Food Safety Standard Older Infant Formula” (GB 10766-2021) and “National Food Safety Standard Young Children Formula” (GB 10767-2021) (hereinafter referred to as the "new national standards"), manufacturers should organize the production of product formulas registered under the new national standards, and applicants are advised to comprehensively consider the time limit for registration application acceptance, review and approval.
